WO2016072126A1

WO2016072126A1 - Lumen passage confirmation device

Info

Publication number: WO2016072126A1
Application number: PCT/JP2015/073345
Authority: WO
Inventors: 啓高杉; 内山　昭夫
Original assignee: オリンパス株式会社
Priority date: 2014-11-06
Filing date: 2015-08-20
Publication date: 2016-05-12
Also published as: JP6006456B1; JPWO2016072126A1; US20170100086A1

Abstract

A lumen passage confirmation device 1 according to the present invention is a device for confirming whether or not a capsule-type medical device to be introduced into the digestive tract in a subject can pass through the digestive tract. The lumen passage confirmation device 1 is equipped with: a main body part 11 which is made from a material that can be dissolved in a substance present in the digestive tract; and a coating layer 12 (a dissoluble layer) which covers the surface of the main body part 11, has an outer diameter that is approximately equal to that of the capsule-type medical device as measured in the direction of the width of the capsule-type medical device, and is made from a material that can be dissolved in a substance present in the digestive tract. The coating layer 12 has, formed therein, two patterns each of which runs around a surface of the coating layer 12 which intersects the longer axis of the lumen passage confirmation device 1, wherein the thickness of at least a portion, which is located in the patterns, of the coating layer 12 is smaller than that of the other portion of the coating layer 12.

Description

Lumen passage confirmation device

The present invention relates to a lumen passage confirmation device for confirming the passage of a capsule medical device introduced into the body of a subject.

In recent years, capsule endoscopes having an imaging function and a wireless communication function have appeared in the field of endoscopes. Capsule endoscopes are used to observe (inspect) the internal organs of the stomach, small intestine, etc., after being swallowed from the mouth of the subject such as a patient and until it is spontaneously discharged from the subject. While moving inside the organ by a peristaltic motion or the like, images of the inside of the organ of the subject (hereinafter also referred to as an in-vivo image) are sequentially taken at intervals of 0.5 seconds, for example. The capsule endoscope sequentially wirelessly transmits the in-vivo images thus captured to the receiving device carried by the subject.

The in-vivo images wirelessly transmitted by the capsule endoscope are sequentially received by the receiving device and sequentially stored in the storage medium of the receiving device. The image display device acquires the in-vivo image group of the subject through the storage medium of the receiving device, and displays the in-vivo image group of the subject on the display. A doctor or nurse observes the in-vivo image displayed on the image display device and diagnoses the subject.

By the way, when such a capsule endoscope has a stenosis within the organ (inside the lumen) of the subject, there is a possibility that the capsule endoscope may stay in the stenosis. For this reason, before performing a capsule endoscopy on a subject, a doctor, a nurse, or the like needs to confirm the lumen passage of the capsule endoscope that the subject takes in. . Therefore, the subject is ingested with a lumen passage confirmation device having an outer diameter almost equal to that of the capsule endoscope to be checked for lumen passage, and whether or not the lumen passage confirmation device has been discharged out of the body, or Based on whether or not the desired organ beyond the organ having the stenosis is reached, it is determined whether or not the capsule endoscope used in the examination can pass through the lumen. For example, as this device for confirming passage of lumen, a capsule-type main body surface composed of a material that is easily dissolved in a living body is substantially made of a low-solubility material so as to have a certain durability in the body of the subject. A lumen coating confirmation device that is uniformly coated has been proposed (for example, see Patent Document 1).

Japanese Patent No. 4307955

When the lumen passage confirmation device described in Patent Document 1 stays in the constricted portion, the thin portion of the coating layer is dissolved due to the variation in the thickness of the coating layer, and the internal body from the portion where the coating layer is dissolved A part of the part is exposed and the whole body part is easily dissolved. However, it takes time for the coating layer to dissolve, and only the coating layer may remain for a long time while maintaining the capsule shape.

The present invention has been made in view of the above circumstances, and is a lumen passage confirmation device in which a coating layer remains in a capsule shape for a long time even when the coating layer remains in the body of a subject. The purpose is to provide.

In order to solve the above-mentioned problems and achieve the object, the lumen passage confirmation device according to the present invention confirms whether or not the capsule medical device introduced into the subject's digestive tract can pass through the digestive tract. A body passage confirmation device that covers the surface of the main body portion and is substantially the same as the outer diameter in the short direction of the capsule medical device. A dissolution layer made of a material that has an equivalent outer diameter and is dissolved by a substance present in the digestive tract, and the dissolution layer circulates around a circumference of a surface that intersects the long axis of the lumen passage confirmation device At least two patterns are formed, and the thickness of the dissolution layer of at least a part of the pattern is smaller than the thickness of the dissolution layer of the other part.

Further, in the lumen passage confirmation device according to the present invention, the main body portion has a cylindrical shape, and the dissolved layer has a thickness of a portion covering a boundary between the bottom surface and the side surface of the cylindrical main body portion. This is characterized in that it is thinner than the thickness of the portion covering the bottom surface and the side surface of the cylindrical main body.

Further, in the lumen passage confirmation device according to the present invention, the main body portion has, on the surface, one or more convex portions formed along one circumference of the surface of the main body portion that intersects the long axis of the lumen passage confirmation device. The melted layer is characterized in that the thickness of the portion covering the convex portion of the main body portion is thinner than the thickness of the portion covering the other portion of the main body portion.

Further, in the lumen passage confirmation device according to the present invention, the dissolution layer has at least one concave portion formed along one circumference of the surface of the dissolution layer intersecting with a long axis of the lumen passage confirmation device. It is characterized by that.

Also, the lumen passage confirmation device according to the present invention is characterized in that the dissolution layer is formed of two layers each containing different identification substances.

The lumen passage confirmation device according to the present invention is characterized in that the identification substance is a contrast agent.

Further, the lumen passage confirmation device according to the present invention is characterized in that the contrast agent contained in the two dissolved layers has a different concentration, thickness, and particle size for each layer. To do.

In the lumen passage confirmation device according to the present invention, the identification substance is a pigment.

Further, in the lumen passage confirmation device according to the present invention, the dissolution layer is formed by two layers of an inner dissolution layer that covers the main body portion and an outer dissolution layer that covers the inner dissolution layer, The dissolution rate of the outer dissolution layer is faster than the dissolution rate of the inner dissolution layer.

Further, the lumen passage confirmation device according to the present invention is characterized in that the dissolution rate of the main body is faster than the dissolution rate of the dissolution layer.

According to the lumen passage confirmation device according to the present invention, a main body portion made of a material that is dissolved by a substance present in the digestive tract, a surface of the main body portion, and an outer diameter in a short direction of the capsule medical device are substantially the same. And a dissolution layer made of a material that dissolves by a substance present in the digestive tract, and the dissolution layer has a pattern that circulates around one circumference of the surface that intersects the long axis of the lumen passage confirmation device. At least two are formed, and the dissolution layer can be divided at a desired portion by making the dissolution layer at least part of the pattern thinner than the dissolution layer of the other part and dissolving faster. Even when the dissolved layer remains in the body of the subject, the dissolved layer does not remain in a capsule shape for a long time.

FIG. 1 is a perspective view of the lumen passage confirmation device according to the first embodiment. FIG. 2 is a cross-sectional view of the lumen passage confirmation device shown in FIG. 1 taken along a plane that includes the major axis of the lumen passage confirmation device and is parallel to the major axis. FIG. 3 is a schematic diagram showing a state in which the lumen passage confirmation device shown in FIG. 1 is taken orally. FIG. 4 is a diagram for explaining how the lumen passage confirmation device shown in FIG. 2 is dissolved in the intestine of the small intestine. FIG. 5 is a cross-sectional view of the lumen passage confirmation device according to the modification of the first embodiment when cut along a plane including the long axis of the lumen passage confirmation device and parallel to the long axis. FIG. 6 is a side view of the main body of the lumen passage confirmation device according to the second embodiment. FIG. 7 is a cross-sectional view of the lumen passage confirmation device according to the second embodiment when cut along a plane including the major axis of the lumen passage confirmation device and parallel to the major axis. FIG. 8 is a diagram for explaining how the lumen passage confirmation device shown in FIG. 7 is dissolved in the intestine of the small intestine. FIG. 9 is a side view of the main body of the lumen passage confirmation device according to the first modification of the second embodiment. FIG. 10 is a cross-sectional view of the lumen passage confirmation device according to the first modification of the second embodiment cut along a plane that includes the major axis of the lumen passage confirmation device and is parallel to the major axis. FIG. 11 is a diagram for explaining how the lumen passage confirmation device shown in FIG. 10 dissolves in the intestinal tract of the small intestine. FIG. 12 is a side view of the main body of the lumen passage confirmation device according to the second modification of the second embodiment. FIG. 13 is a diagram for explaining how the lumen passage confirmation device shown in FIG. 12 is dissolved in the intestine of the small intestine. FIG. 14 is a side view of the main body portion of the lumen passage confirmation device according to the third modification of the second embodiment. FIG. 15 shows a case where the lumen passage confirmation device according to the third modification of the second embodiment is cut along a plane perpendicular to the long axis of the lumen passage confirmation device and passing through the convex portion of the main body. It is sectional drawing. FIG. 16 is a side view of the lumen passage confirmation device according to the third embodiment. FIG. 17 is a cross-sectional view of the lumen passage confirmation device according to the third embodiment when cut along a plane that includes the major axis of the lumen passage confirmation device and is parallel to the major axis. FIG. 18 is a side view of the lumen passage confirmation device according to the first modification of the third embodiment. FIG. 19 is a side view of the lumen passage confirmation device according to the second modification of the third embodiment. FIG. 20 is a side view of the lumen passage confirmation device according to the third modification of the third embodiment. 21 is a cross-sectional view taken along line AA in FIG. FIG. 22 is a cross-sectional view of the lumen passage confirmation device according to the fourth embodiment when cut along a plane that includes the major axis of the lumen passage confirmation device and is parallel to the major axis. FIG. 23 is a view showing an X-ray image of the lumen passage confirmation apparatus in a state where the first coating layer shown in FIG. 22 remains on the entire surface of the apparatus. FIG. 24 is a view showing an X-ray image of the lumen passage confirmation apparatus in a state where the first coating layer shown in FIG. 22 is dissolved and the second coating layer is exposed. FIG. 25 is a cross-sectional view of another lumen passage confirmation device according to the fourth embodiment cut along a plane including the major axis of the lumen passage confirmation device and parallel to the major axis. FIG. 26 is a cross-sectional view of another lumen passage confirmation device according to the fourth embodiment cut along a plane that includes the long axis of the lumen passage confirmation device and is parallel to the long axis. FIG. 27 is a cross-sectional view of the lumen passage confirmation device according to the fifth embodiment cut along a plane that includes the long axis of the lumen passage confirmation device and is parallel to the long axis.

Hereinafter, preferred embodiments of a lumen passage confirmation device according to the present invention will be described in detail with reference to the drawings. Hereinafter, a capsule-shaped device will be described as an example of the lumen passage confirmation device according to the present invention. Moreover, this invention is not limited by this embodiment. Furthermore, the same code | symbol is attached | subjected to the same part in description of drawing.

(Embodiment 1)
FIG. 1 is a perspective view of the lumen passage confirmation device according to the first embodiment. As shown in FIG. 1, the lumen passage confirmation device 1 according to the first embodiment confirms whether or not the capsule medical device introduced into the subject's digestive tract can pass through an organ to be confirmed for passage. Device. For this reason, the lumen passage confirmation device 1 is formed to have the same outer shape as the capsule medical device introduced into the subject's digestive tract so that it can be introduced into the subject's digestive tract. The outer diameter of the medical device is approximately the same as the outer diameter in the short direction. The lumen passage confirmation device 1 has, for example, a substantially cylindrical shape. Even when external pressure is applied by peristaltic movement of an organ, the lumen passage confirmation device 1 has an outer diameter that is substantially the same as that of the capsule medical device to be introduced, and has the same outer shape as that of the capsule medical device. maintain.

FIG. 2 is a cross-sectional view of the lumen passage confirmation device 1 shown in FIG. 1 taken along a plane that includes the long axis La of the lumen passage confirmation device 1 and is parallel to the long axis La. As shown in FIG. 2, the lumen passage confirmation device 1 includes a main body 11 having a cylindrical shape, and a coating layer (dissolving layer) 12 that coats (covers) the outer surface of the main body 11.

The main body 11 is made of a material that is dissolved by a substance that exists in the digestive tract, which is an organ to be confirmed for passage of the capsule medical device, and is made of a material that dissolves more easily than the coating layer 12. Is faster than the dissolution rate of the coating layer 12 described later. Since the main body 11 has a cylindrical shape, a circumferential portion 11e (see FIG. 2), which is a boundary between the bottom surface and the side surface, circulates along each outer periphery of the two bottom surfaces of the column. When examining whether the intestinal tract of the small intestine can pass, the target organ of the lumen passage confirmation device 1 is the large intestine, and the main body 11 is a liquid (intestinal juice or digestive fluid) present in the small intestine and the intestinal tract of the large intestine. ) And enteric material that dissolves in a short time.

The coating layer 12 has an outer diameter substantially equal to the outer diameter in the short direction of the capsule medical device to be introduced, and is made of a material that is dissolved by a substance present in the digestive tract to be confirmed for passage. The coating layer 12 has a substantially cylindrical shape in which both ends are closed in order to include the columnar main body 11. The coating layer 12 is made of a material that is dissolved by at least a liquid (intestinal juice or digestive juice) present in the digestive tract to be confirmed to pass through the capsule medical device. When inspecting whether the small intestine can pass through the intestinal tract, the target organ of the lumen passage confirmation device 1 is the large intestine, and the coating layer 12 is dissolved with time by the liquid present in the small intestine and the intestinal tract of the large intestine. Consisting of enteric material. For example, the coating layer 12 is formed of a general enteric material such as gelatin that gradually dissolves in both the small intestine and the large intestine. The enteric material is dissolved by digestive fluid in the intestine. Moreover, the coating layer 12 is formed by spraying or vapor-depositing an enteric material etc. on the main-body part 11, for example.

In the coating layer 12, the thickness Te of the portion coated with the circumferential portion 11e of the main body portion 11 shown in the region Se is thinner than the thickness Tf of the portion coated with the side surface and the bottom surface of the main body portion 11. In other words, in the coating layer 12, the thickness Te of the portion coated with the circumferential portion 11e of the main body portion 11 that circulates along the outer periphery of the bottom surface that intersects the long axis La of the lumen passage confirmation device 1 is the other portion. It is thinner than the thickness Tf.

For example, as shown in FIG. 3, the lumen passage confirmation device 1 having such a configuration is orally ingested by a subject K before introducing the capsule medical device into the body (specifically, orally ingesting). The The lumen passage confirmation device 1 taken orally by the subject K advances inside the lumen of the subject K by a peristaltic motion or the like. When there is no stenosis inside the lumen of the subject K, the lumen passage confirmation device 1 reaches the intended large intestine or is discharged out of the body.

On the other hand, when there is a stenosis part inside the lumen of the subject K, the lumen passage confirmation device 1 stays in this stenosis part. Note that the lumen passage confirmation device 1 maintains its shape with the coating layer 12 until it reaches the small intestine. When the lumen passage confirmation device 1 stays in the stenosis of the small intestine, it dissolves with time.

FIG. 4 is a diagram for explaining how the lumen passage confirmation device 1 is dissolved in the intestinal tract of the small intestine. When the lumen passage confirmation device 1 stays in the small intestinal stenosis P as shown in FIG. 4A, the coating layer 12 has two circumferential portions in the region Se as shown in FIG. 4B. The thin part that coats 11e dissolves before the other parts. As a result, the coating layer 12 is divided into

portions

12b and 12d that cover the bottom surface of the main body portion 11 and

cylindrical portions

12a and 12c that cover the side surfaces of the main body portion 11, and the circle of the main body portion 11 is formed through the gaps between the portions 12a to 12d. The surface of the peripheral part 11e is exposed. As shown by the arrow in (2) of FIG. 4, the liquid existing in the small intestine enters from the exposed circumferential portion 11e of the main body 11, and the entire main body 11 is dissolved as shown in (3) of FIG. To do. As a result, in the divided coating layer 12, the

portions

12 b and 12 d that covered the bottom surface of the main body 11 fall down to the inside of the

cylindrical portions

12 a and 12 c that covered the side surface of the main body 11, and the coating layer 12. Remains in a state where at least both ends of the cylindrical shape are inserted. Therefore, even when the lumen passage confirmation device 1 stays in the stenosis P and the coating layer 12 remains, intestinal fluid or the like can pass through the coating layer 12 as indicated by the arrow in FIG.

As described above, in the first embodiment, in the coating layer 12, the thickness of the portion to be divided is made thinner than the thickness of the other portions, so that the coating layer 12 can be divided at a desired portion. . In the lumen passage confirmation device 1, the coating layer 12 coats the thickness of a pattern that circulates around one round of the cross section intersecting with the long axis La of the lumen passage confirmation device 1, for example, the circumferential portion 11 e of the main body portion 11. By making the thickness of the portion thinner than the thickness of the other portions, the bottom surface portion of the coating layer 12 having a substantially cylindrical shape is separated from the cylindrical portion portion. As a result, even when the lumen passage confirmation device 1 stays in the narrowed portion P and the coating layer 12 remains in the intestinal tract, intestinal fluid and the like can pass through the cylindrical coating layer 12 inserted at both ends. The influence on the living body can be reduced.

(Modification of Embodiment 1)
FIG. 5 is a cross-sectional view of the lumen passage confirmation device according to the modification of the first embodiment when cut along a plane including the major axis of the lumen passage confirmation device and parallel to the major axis. As shown in the lumen passage confirmation device 1A in FIG. 5, the coating layer is generated by being divided into

cylindrical portions

121 and 123 that cover the side surfaces of the main body portion 11 and

bottom surface portions

122 and 124 that cover the bottom surface of the main body portion 11. The

cylindrical portions

121 and 123 and the

bottom surface portions

122 and 124 may be bonded with the adhesive 13. In this case, the coating layer is dissolved from the boundary portion between the

cylindrical portions

121 and 123 and the

bottom surface portions

122 and 124, and the

cylindrical portions

121 and 123 and the

bottom surface portions

122 and 124 are divided.

(Embodiment 2)
Next, a second embodiment will be described. FIG. 6 is a side view of the main body of the lumen passage confirmation device according to the second embodiment. FIG. 7 is a cross-sectional view of the lumen passage confirmation device 201 according to the second embodiment cut along a plane that includes the long axis Lb of the lumen passage confirmation device 201 and is parallel to the long axis Lb.

As shown in FIG. 6, in the lumen passage confirmation device 201 according to the second embodiment, two convex portions 211p are formed on the outer surface on the end side of the body portion 211 having a capsule shape. The convex portion 211p circulates over one round of the cross section of the main body portion 211 orthogonal to the long axis Lb of the lumen passage confirmation device 201. For this reason, as shown in FIG. 7, the coating layer 212 that coats the outer surface of the main body 211 has a thickness Tp of the portion coated with the convex portion 211 p of the main body 211 in the region Sp. It becomes thinner than the thickness Tg of the part which coated this part.

FIG. 8 is a diagram for explaining how the lumen passage confirmation device 201 dissolves in the intestinal tract of the small intestine. As shown in (1) of FIG. 8, when the lumen passage confirmation device 201 stays in the stenosis portion P of the small intestine, as shown in (2) of FIG. 8, in the coating layer 212, the convex portion 211p in the region Sp is formed. The thin part to be coated dissolves before the other part. That is, in the coating layer 212, a hole that circulates along one round of the cross section orthogonal to the long axis Lb of the lumen passage confirmation device 201 corresponds to the formation part of the convex portion 211p, and the coating layer 212 211 is divided into

cylindrical portions

212 a and 212 c that cover the trunk, and

portions

212 b and 212 d that cover the ends of the main body 211. Accordingly, the surface of the convex portion 211p of the main body 211 is exposed from the gap between the portions 212a to 212d. Then, as shown by the arrow in (2) of FIG. 8, the liquid existing in the small intestine enters from the exposed convex portion 211p of the main body 211, and as shown in (3) of FIG. When dissolved, each portion of the divided coating layer 212 is separated, and at least the

cylindrical portions

212a and 212c of the coating layer 212 are inserted into both ends, and the inside of the coating layer 212 is intestinal fluid or the like as indicated by arrows. Can pass.

As described above, in the second embodiment, the surface of the main body portion 211 is provided with the convex portion 211p that circulates around one round of the cross section orthogonal to the long axis Lb of the lumen passage confirmation device 201, thereby coating the convex portion 211p. The thickness of the layer 212 is made thinner than the thickness of the other part of the coating layer 212. That is, in the coating layer 212, the thickness of the cross section of the pattern on the convex portion 211p that circulates over one circumference of two cross sections orthogonal to the long axis Lb of the lumen passage confirmation device 201 is set to a portion that coats portions other than the convex portion 211p. It is thinner than the thickness. As a result, in the lumen passage confirmation device 201, the pattern portion of the coating layer 212 on the convex portion 211p is rapidly dissolved, and the remaining coating layer 212 is divided into a cylindrical portion where at least both ends are inserted and other portions. Thus, the same effects as those of the first embodiment are obtained. In the second embodiment, the convex portion 211p circulates over one round of the surface cut by a plane orthogonal to the long axis Lb of the lumen passage confirmation device 201, and circulates over one round of the curved surface intersecting with the long axis Lb. Also good.

(Modification 1 of Embodiment 2)
FIG. 9 is a side view of the main body of the lumen passage confirmation device according to the first modification of the second embodiment. FIG. 10 is a cross-sectional view of the lumen passage confirmation device 201A according to the first modification of the second embodiment cut along a plane that includes the long axis Lc of the lumen passage confirmation device 201A and is parallel to the long axis Lc. .

As shown in FIGS. 9 and 10, the lumen passage confirmation device 201A according to the first modification of the second embodiment circulates around the entire circumference of the cross section that intersects the long axis Lc of the lumen passage confirmation device 201A on the main body portion 211A. Two convex portions 211q are formed. Also in this case, in the coating layer 212A that coats the outer surface of the main body 211A, the thickness Tg of the part coated on the convex part 211q of the main body 211A is the thickness of the part that coats the other part of the main body 211A. It becomes thinner than Th. For this reason, when the lumen passage confirmation device 201A stays in the constricted portion of the small intestine, in the coating layer 212A, the thin portion that coats the convex portion 211q is dissolved before the other portions, 11, it is divided into

end portions

212e and 212g and a cylindrical portion 212f. Accordingly, at least the cylindrical portion 212f of the coating layer 212A is in a state where both ends are inserted, and intestinal fluid or the like can pass through the coating layer 212A. In order to divide the coating layer remaining in the body into the end portion side portion and the cylindrical portion, it is not necessarily limited to the cross section orthogonal to the long axis of the lumen passage confirmation device, and the convex portion 211q formed on the main body portion 211A. As described above, it is sufficient to form the convex portion so as to circulate around the entire circumference of the cross section intersecting with the long axis of the lumen passage confirmation device. Note that the convex portion 211q may circulate around one round of the curved surface that intersects the long axis Lc of the lumen passage confirmation device 201A.

(Modification 2 of Embodiment 2)
FIG. 12 is a side view of the main body of the lumen passage confirmation device according to the second modification of the second embodiment.

As shown in FIG. 12, in the lumen passage confirmation device according to the second modification of the second embodiment, the main body portion 211 B has a main surface 211 B in a plane including the long axis Ld in addition to the two convex portions 211 p. A convex portion 211r that circulates around the cut section is formed. Also in this case, the coating layer for coating the outer surface of the main body part 211B has a thickness of the portion coated on the

convex portions

211p and 211r of the main body part 211B is larger than the thickness of the part coated on the other part of the main body part 211B. Also become thinner. When the lumen passage confirmation device according to the second modification of the second embodiment stays in the stenosis of the small intestine, in the coating layer, the thinner part that coats the

convex portions

211p and 211r is more than the other part. 13, the end portions 212j to 212m are divided at the position of the convex portion 211r, and the cylindrical portions are divided at the position of the convex portion 211r, as shown in FIG. And divided.

Thus, not only the convex part that circulates around the circumference of the cross section that intersects the long axis of the lumen passage confirmation device, but also the convexity that circulates around the circumference of the cross section of the main body section cut by a plane including the long axis of the lumen passage confirmation device. A part may be formed so that the coating layer of the lumen passage confirmation device can be further finely divided along a plane passing through the long axis.

(Modification 3 of Embodiment 2)
FIG. 14 is a side view of the main body portion of the lumen passage confirmation device according to the third modification of the second embodiment. 15 shows a lumen passage confirmation device 201C according to the third modification of the second embodiment cut along a plane perpendicular to the long axis Le of the lumen passage confirmation device 201C and passing through the convex portion of the main body. It is sectional drawing in the case.

As shown in FIGS. 14 and 15, in the lumen passage confirmation device 201C according to the third modification of the second embodiment, a plurality of convex portions 211s are provided on the main body portion 211C and the long axis Le of the lumen passage confirmation device 201C. Two sets are formed along one circumference of the cross section of the main body portion 211 C that intersects with. In other words, as shown in FIG. 15, the main body portion 211C of the lumen passage confirmation device 201C is not a convex portion that goes around the entire circumference of the cross section intersecting with the long axis Le of the lumen passage confirmation device 201C. Two sets of a plurality of convex portions 211s partially formed along one circumference of a cross section intersecting with the long axis Le of the confirmation device 201C are formed. Also in this case, in the coating layer 212C that coats the outer surface of the main body part 211C, the thickness Tj of the part coated on the convex part 211s of the main body part 211C is the thickness of the part that covers the other part of the main body part 211C. Thinner than Ti.

When the lumen passage confirmation device 201C according to the third modification of the second embodiment stays in the stenosis portion of the small intestine, in the coating layer 212C, the thin portion that coats the convex portion 211s is ahead of the other portions. And a perforated hole is opened in accordance with the position of the convex portion 211s, so that it is easily divided from the position where the convex portion 211s is formed into both end portions and the cylindrical portion side. Note that the convex portion 211s may circulate around one round of the curved surface that intersects the long axis Le of the lumen passage confirmation device 201C.

(Embodiment 3)
Next, Embodiment 3 will be described. FIG. 16 is a side view of the lumen passage confirmation device according to the third embodiment. FIG. 17 is a cross-sectional view of the lumen passage confirmation device 301 according to the third embodiment cut along a plane that includes the long axis Lf of the lumen passage confirmation device 301 and is parallel to the long axis Lf.

As shown in FIGS. 16 and 17, in the lumen passage confirmation device 301, the main body 311 has a capsule shape with a smooth surface, and the surface of the coating layer 312 containing the main body 311 has a lumen. Two recesses 312d are formed that circulate along one circumference of the cross section orthogonal to the long axis Lf of the passage confirmation device 301. The recess 312d is formed by coating the entire surface of the main body 311 with the same thickness with an enteric material or the like constituting the coating layer, and then embossing with a convex member or cutting a groove on the surface of the coating layer. Is done.

For this reason, as shown in FIG. 17, in the coating layer 312, the thickness Tm in the recess 312 d in the region Sd is thinner than the thickness Tk of other portions. For this reason, when the lumen passage confirmation device 301 stays in the constricted portion of the small intestine, in the coating layer 312, the thin portion of the concave portion 312d dissolves before the other portions, thereby forming the concave portion 312d. Corresponding to the location, a hole that circulates along one circumference of the cross section orthogonal to the long axis Lf of the lumen passage confirmation device 301 is opened, and is divided into an end portion side portion and a cylindrical portion. Accordingly, at least the cylindrical portion of the coating layer 312 is in a state where both ends are inserted, and the intestinal fluid and the like can pass through the inside of the coating layer 312. Therefore, the same effect as in the first embodiment can be obtained. Note that the recess 312d may circulate around one round of the curved surface that intersects the long axis Lf of the lumen passage confirmation device 301.

(Modification 1 of Embodiment 3)
FIG. 18 is a side view of the lumen passage confirmation device according to the first modification of the third embodiment. As illustrated in FIG. 18, the lumen passage confirmation device 301A according to the first modification of the third embodiment is provided with a recess 312e that circulates in the coating layer 312A over the entire circumference of the cross section intersecting the long axis Lg of the lumen passage confirmation device 301A. Two are formed. As in this lumen passage confirmation device 301A, when two concave portions 312e are formed on the surface of the coating layer 312A around the section of the lumen passage confirmation device 301A that intersects the long axis Lg, The coating layer remaining in the body can be divided into an end side portion and a cylindrical portion. Note that the recess 312e may circulate around one round of the curved surface that intersects the long axis Lg of the lumen passage confirmation device 301A.

(Modification 2 of Embodiment 3)
FIG. 19 is a side view of the lumen passage confirmation device according to the second modification of the third embodiment. As shown in FIG. 19, in the lumen passage confirmation device 301B according to the second modification of the third embodiment, the lumen passage confirmation device 301B is formed on the surface of the coating layer 312B as compared with the lumen passage confirmation device 301. A recess 312f that circulates around the entire circumference of the cross section cut by the plane including the long axis Lh is further formed so that the coating layer 312B of the lumen passage confirmation device 301B can be further divided along the plane passing through the long axis Lh. ing.

(Modification 3 of Embodiment 3)
FIG. 20 is a side view of the lumen passage confirmation device according to the third modification of the third embodiment. 21 is a cross-sectional view taken along line AA in FIG.

As shown in FIGS. 20 and 21, in the lumen passage confirmation device 301 C according to the third modification of the third embodiment, the coating layer 312 C is provided around the cross section orthogonal to the long axis Li of the lumen passage confirmation device 301 C. Two sets of a plurality of concave portions 312g partially formed along the line are provided. Also in this case, in the coating layer 312C, the thickness To of the portion where the recess 312g is formed is thinner than the thickness Tn of the other portion. When the lumen passage confirmation device 301C stays in the constricted portion of the small intestine, in the coating layer 312C, the thin recessed portion 312g is dissolved before the other portions, and perforated holes are aligned with the position of the recessed portion 312g. Will open, and it will become easy to divide into the both ends and the cylindrical part side from the position in which the recessed part 312g was formed. Note that the recess 312g may circulate around one round of the curved surface that intersects the long axis Li of the lumen passage confirmation device 301C.

(Embodiment 4)
Next, a fourth embodiment will be described. The fourth embodiment relates to a lumen passage confirmation device capable of confirming passage of lumens for capsule endoscopes of different sizes.

FIG. 22 is a cross-sectional view of the lumen passage confirmation device according to the fourth embodiment cut along a plane that includes the long axis of the lumen passage confirmation device and is parallel to the long axis. As shown in FIG. 22, the lumen passage confirmation device 401 according to the fourth embodiment has a configuration in which the coating layer 412 is formed in two layers as compared with the lumen passage confirmation device 201 according to the second embodiment. Have. As in the second embodiment, when the lumen passage confirmation device 401 stays in the stenosis of the small intestine, the coating layer 412 is divided so that the remaining coating layer 412 is divided into an end portion side portion and a cylindrical portion. The thickness Tpa of the portion coated on the outer surface of the convex portion 211p of the main body portion 211 shown in the region Spa is thinner than the thickness Tga of the portion coated with the other portion of the main body portion 211.

The coating layer 412 has an outer first coating layer 413 and an inner second coating layer 414. The second coating layer 414 coats the surface of the main body 211, and the first coating layer 413 coats the second coating layer 414. In order to confirm the lumen passage of the capsule endoscope having the outer diameter A1, the first coating layer 413 has an inner diameter A1 having the same diameter as that of the capsule endoscope having the outer diameter A1. In order to confirm the lumen passage of the capsule endoscope having the outer diameter A2 (<outer diameter A1), the second coating layer 414 has an inner diameter A2 having the same diameter as the capsule endoscope having the outer diameter A2. . That is, in Embodiment 4, the outer diameter of the main body 211 is the same as that of the capsule endoscope having the outer diameter A2.

The first coating layer 413 dissolves in the small intestine and large intestine, and dissolves in the small intestine and large intestine in about 40 hours, for example. The second coating layer 414 dissolves in the small intestine and large intestine, and dissolves in the small intestine and large intestine, for example, in about 30 hours. In the small intestine and the large intestine, the thicknesses of the first coating layer 413 and the second coating layer 414 are adjusted so as to dissolve in a desired time.

The first coating layer 413 and the second coating layer 414 include different identification substances. The first coating layer 413 and the second coating layer 414 contain different concentrations of X-ray contrast agents as identification substances. The first coating layer 413 includes an X-ray contrast medium having a concentration D1, and the second coating layer 414 includes an X-ray contrast medium having a concentration D2. In order to distinguish the boundary between the first coating layer 413 and the second coating layer 414 when X-ray imaging is performed, the concentration D2 of the X-ray contrast medium included in the second coating layer 414 is determined by the first coating layer 413. The density is set to be higher than the concentration D1 of the X-ray contrast medium to be included.

A lumen passage confirmation test using this lumen passage confirmation device 401 will be described. First, the subject K is orally ingested with the lumen passage confirmation device 401, and patency confirmation is performed, for example, around 30 hours after ingestion. At this time, when the lumen passage confirmation device 401 is discharged from the body, it can be determined that the capsule endoscope having the outer diameter A1 can be opened. Moreover, if the patency in the small intestine region with a narrow lumen can be confirmed, it may be considered that the patency of the entire digestive tract has been confirmed. Therefore, even when the lumen passage confirmation device 401 reaches the large intestine which is an organ after the small intestine, and the first coating layer 413 remains on the entire surface of the device, the outer diameter A1 is also reduced. It can be determined that the capsule endoscope can be opened. In this case, the lumen passage confirmation device 401 in the body of the subject K is X-rayed, and the remaining state of the first coating layer 413 is determined based on the imaging result.

FIG. 23 is a view showing an X-ray image of the lumen passage confirmation device 401 in a state where the first coating layer 413 remains on the entire surface of the device. Since the X-ray contrast medium concentration D2 of the inner second coating layer 414 is higher than the X-ray contrast medium concentration D1 of the outer first coating layer 413, on the X-ray image, the second coating layer 414 is It appears darker than the first coating layer 413, and the boundary between the first coating layer 413 and the second coating layer 414 can be recognized. Specifically, as shown in an image 401g in FIG. 23, when the first coating layer 413 remains on the entire surface of the device, the lumen passage confirmation device 401 includes the main body 211 and the second coating layer 414. The first coating layer 413 is thinly projected as a layer surrounding the outer periphery of the capsule image. When an image 401g as shown in FIG. 23 is located in the large intestine in this X-ray imaging for lumen passage confirmation, the lumen passage confirmation device 401 has the outermost first coating layer 413 of the device. Since it can be determined that the large intestine has been reached while remaining on the entire surface, it can be determined that the capsule endoscope having the same outer diameter A1 as the inner diameter A1 of the first coating layer 413 can pass through the small intestine. It can be evaluated that the capsule endoscope having the outer diameter A1 has patency.

Further, when it is not possible to grasp the discharge of the lumen passage confirmation device 401 to the outside of the body or the arrival to the large intestine, the patency check is performed again after taking the lumen passage confirmation device 401, for example, around 60 hours. I do. In this case, since 60 hours have passed since the ingestion of the lumen passage confirmation device 401, it can be determined that the first coating layer 413 is dissolved in the intestine. For this reason, when the lumen passage confirmation device 401 is discharged from the body at this time, it can be determined that the capsule endoscope having the outer diameter A2 can be opened. Further, even when the lumen passage confirmation device 401 reaches the large intestine and the first coating layer 413 is dissolved and the second coating layer 414 is exposed, the capsule endoscope having the outer diameter A2 is used. It can be judged that the opening of the service is possible. Also in this case, X-ray imaging is performed on the lumen passage confirmation device 401 in the body of the subject K, and it is determined whether or not the second coating layer 414 is exposed based on the imaging result.

FIG. 24 is a diagram showing an X-ray image of the lumen passage confirmation device 401 in a state where the first coating layer 413 is dissolved and the second coating layer 414 is exposed. Since 60 hours have already passed since ingestion, the outermost first coating layer 413 is dissolved. When the second coating layer 414 inside the first coating layer 413 is exposed, the lumen passage confirmation device 401 displays the body part 211 and the second coating layer 414 darkly as a dark capsule image. An image 401f (see FIG. 24) can be acquired. When this image 401f is located in the large intestine, it can be understood that the lumen passage confirmation device 401 can reach the large intestine with the inner second coating layer 414 remaining on almost the entire surface of the device. It can be judged that the capsule endoscope having the same outer diameter A2 as the inner diameter A2 of the second coating layer 414 can pass through the small intestine, and that the capsule endoscope having the outer diameter A2 has patency. . On the other hand, when an image in which the second coating layer 414 is not left on the surface of the apparatus is acquired, there is no patency of the capsule endoscope having the outer diameter A2 for the subject K. Can be evaluated.

As described above, in the fourth embodiment, the same effects as in the first embodiment are obtained, the coating layer is formed in two layers, and the concentration of each X-ray contrast agent is changed for each layer, and the two coating layers are formed. Can be identified on the X-ray image, it is possible to evaluate the patency of capsule endoscopes of different sizes (outer diameters A1, A2) in one patency evaluation test.

In the fourth embodiment, the concentration of the X-ray contrast agent, the particle size of the X-ray contrast agent, or the first coating layer 413 and the second coating layer 414 can be distinguished from each other on the X-ray image. Any one or more of the thicknesses of the coating layer 413 and the second coating layer 414 may be changed.

Also, the dissolution rate of the outer first coating layer 413 of the first coating layer 413 and the second coating layer 414 may be faster than the dissolution rate of the inner second coating layer. By adjusting in this way, it is possible to lengthen the time that the first coating layer 413 is completely dissolved in the small intestine and large intestine and only the second coating layer 414 remains in the small intestine and large intestine. Even if there is a lumen part substantially equal to the outer diameter A2, the patency of the capsule endoscope having the outer diameter A2 can be appropriately confirmed. In this case, at least one of the concentration of the enteric material contained in the first coating layer 413 and the second coating layer 414, the particle size of the enteric material, or the thicknesses of the first coating layer 413 and the second coating layer 414 is used. By changing the above, the dissolution rate of the first coating layer 413 is set faster than the dissolution rate of the second coating layer 414.

Further, although the X-ray contrast agent has been described as an example of the identification material for identifying the first coating layer 413 and the second coating layer 414, a dye may be used as the identification material. In this case, the first coating layer 413 and the second coating layer 414 include pigments of different colors that can be visually discerned, so that the color of the surface of the lumen passage confirmation device discharged outside the body can be determined. Check it. When the color of the surface of the lumen passage confirmation device discharged outside the body is a color corresponding to the pigment contained in the first coating layer 413, the first coating layer 413 remains on the entire surface of the device Since it can be determined that the lumen passage confirmation device has been discharged from the body, it can be determined that the capsule endoscope having the outer diameter A1 can be opened. When the color of the surface of the lumen passage confirmation device discharged out of the body is a color corresponding to the pigment contained in the second coating layer 414, the first coating layer 413 is dissolved and the second coating layer 414 becomes the device. Since it can be determined that the lumen passage confirmation device has been discharged from the body while remaining on the entire surface, it can be determined that the capsule endoscope having the outer diameter A2 can be opened. Note that the color of the surface of the lumen passage confirmation device discharged out of the body may be either a color corresponding to the pigment included in the first coating layer 413 or a color corresponding to the pigment included in the second coating layer 414. In the case where the first coating layer 413 and the second coating layer 414 are not dissolved and remain on the surface, the capsule-type endoscope having the outer diameter A2 is provided for the subject K. It can be evaluated that the mirror is not open.

Also, the fourth embodiment can be applied to the first embodiment. FIG. 25 is a cross-sectional view of another lumen passage confirmation device according to the fourth embodiment cut along a plane including the major axis of the lumen passage confirmation device and parallel to the major axis. The coating layer 12 of the lumen passage confirmation device 1 according to the first embodiment is divided into two layers, a first coating layer 413A and a second coating layer 414A, each containing different identification substances, like the lumen passage confirmation device 401A of FIG. A capsule endoscope having an outer diameter equal to the inner diameter A3 of the first coating layer 413A, and a capsule endoscope having an outer diameter equal to the inner diameter A4 of the second coating layer 414A. You may enable it to perform patency confirmation with respect to a mirror. Of course, as in the first embodiment, in the coating layer 412A, as shown in the region Sea, the thickness of the portion coated on the outer surface of the circumferential portion 11e of the main body portion 11 is the other portion of the main body portion 11. It is thinner than the thickness of the coated part.

Also, the fourth embodiment can be applied to the third embodiment. FIG. 26 is a cross-sectional view of another lumen passage confirmation device according to the fourth embodiment cut along a plane that includes the long axis of the lumen passage confirmation device and is parallel to the long axis. The coating layer 312 of the lumen passage confirmation device 301 according to the third embodiment is divided into two layers, a first coating layer 413B and a second coating layer 414B, each containing a different identification substance, like the lumen passage confirmation device 401B of FIG. A capsule endoscope having an outer diameter equal to the inner diameter A5 of the first coating layer 413B and a capsule endoscope having an outer diameter equal to the inner diameter A6 of the second coating layer 414B. You may enable it to perform patency confirmation with respect to a mirror. Of course, as in the third embodiment, the coating layer 412B is provided with two recesses 412d.

(Embodiment 5)
Next, a fifth embodiment will be described. FIG. 27 is a cross-sectional view of the lumen passage confirmation device according to the fifth embodiment cut along a plane that includes the major axis of the lumen passage confirmation device and is parallel to the major axis.

As shown in FIG. 27, in the lumen passage confirmation device 501 according to the fifth embodiment, a coating layer 512 having almost the same thickness is formed on the surface of the main body 311. The coating layer 512 includes a first coating layer 513 and a second coating layer 514, and each of the first coating layer 513 and the second coating layer 514 includes different identification substances as in the fourth embodiment.

Therefore, in the lumen passage confirmation device 501, the capsule endoscope having the same outer diameter as the inner diameter A7 of the first coating layer 513 and the capsule having the outer diameter same as the inner diameter A8 of the second coating layer 514 are used. The patency with respect to the type endoscope can be confirmed, and the patency with respect to the capsule type endoscopes having different sizes (outer diameters A7 and A8) can be evaluated in one patency evaluation test.

Of course, in the fifth embodiment, similarly to the fourth embodiment, the outer first coating layer 513 may be formed so that the dissolution rate thereof is higher than the dissolution rate of the inner second coating layer 514. .

Furthermore, in Embodiments 1 to 5 and the modifications of the present invention, the digestive tract to be confirmed for passage of the capsule medical device is the small intestine, and the target organ of the lumen passage confirmation device is the large intestine. Not limited to this, the target organ of the capsule medical device may be any organ in the digestive tract from the esophagus to the large intestine as long as it is an organ corresponding to the digestive tract to be confirmed for passage. In this case, a coating layer containing an identification substance for confirming whether or not the lumen passage confirmation device has reached the target organ of the capsule medical device is present in the digestive tract and target organ of the passage confirmation target It may be formed using a material that dissolves depending on the substance to be treated.

1, 1A, 201, 201A, 201C, 301, 301A, 301B, 301C, 401, 401A, 401B, 501 Lumen

passage confirmation device

11, 211, 211A, 211B, 211C, 311 Main body portion

11e Circumferential portion

12, 212 212A, 212C, 312, 312A, 312B, 312C, 412, 412A, 412B, 512 Coating layer 13 Adhesive 211p, 211q, 211r,

211s Convex part

312d, 312e, 312f, 312g, 412d

Concave part

413, 413A, 413B, 513

First coating layer

414, 414A, 414B, 514 Second coating layer

Claims

A lumen passage confirmation device for confirming whether or not a capsule medical device introduced into a subject's digestive tract can pass through the digestive tract,
A body made of a material that is dissolved by a substance present in the digestive tract;
Covering the surface of the main body, having an outer diameter substantially equal to the outer diameter in the short direction of the capsule medical device, and a dissolution layer made of a material that dissolves by a substance present in the digestive tract;
With
The dissolved layer is formed with at least two patterns that circulate around one circumference of the surface intersecting with the long axis of the lumen passage confirmation device, and the thickness of the dissolved layer of at least a part of the pattern is the other part. A lumen passage confirmation device characterized in that it is thinner than the thickness of the dissolved layer.
The main body has a cylindrical shape,
The thickness of the portion of the dissolution layer covering the boundary between the bottom surface and the side surface of the columnar body portion is thinner than the thickness of the portion covering the bottom surface and the side surface of the columnar body portion. The lumen passage confirmation device according to claim 1.
The main body has one or more protrusions formed on the surface along one circumference of the surface of the main body that intersects with the long axis of the lumen passage confirmation device,
2. The lumen passage according to claim 1, wherein the dissolution layer has a thickness of a portion covering the convex portion of the main body portion thinner than a thickness of a portion covering the other portion of the main body portion. Confirmation device.
2. The lumen according to claim 1, wherein the dissolution layer has one or more concave portions formed along a circumference of a surface of the dissolution layer intersecting with a long axis of the lumen passage confirmation device. Pass confirmation device.
2. The lumen passage confirmation device according to claim 1, wherein the dissolution layer is formed of two layers each containing different identification substances.
6. The lumen passage confirmation device according to claim 5, wherein the identification substance is a contrast agent.
7. The lumen passage confirmation device according to claim 6, wherein the contrast agent contained in the two dissolved layers has a different concentration, thickness, and particle size for each layer.
6. The lumen passage confirmation device according to claim 5, wherein the identification substance is a pigment.
The dissolution layer is formed by two layers of an inner dissolution layer covering the main body portion and an outer dissolution layer covering the inner dissolution layer,
6. The lumen passage confirmation device according to claim 5, wherein the dissolution rate of the outer dissolution layer is faster than the dissolution rate of the inner dissolution layer.
2. The lumen passage confirmation device according to claim 1, wherein the dissolution rate of the main body is faster than the dissolution rate of the dissolution layer.